Report of the PMDA-ATC/AMDC Medical Devices Webinar 2023

On December 4, 2023, the PMDA, in collaboration with the ASEAN Medical Device Committee (AMDC), held the “PMDAATC/AMDC Medical Devices Webinar 2023.” The webinar aimed at providing a platform for medical device regulators in ASEAN Member States to deepen their knowledge of the medical device regulatory system by sharing experiences between ASEAN Member States and Japan. Eighteen regulators engaged in reviews and postmarket safety measures for medical devices participated in the webinar. Dr. UZU Shinobu, Director of the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs of the PMDA, inaugurated the webinar with opening remarks. Subsequently, PMDA staff members shared information on the regulatory framework and the PMDA’s experiences in safety measures and quality management sysytem based on international standards and documents from the Global Harmonization Task Force (GHTF)/International Medical Device Regulators Forum (IMDRF). 

See attached program